MalfunctionDTY
TERUMO CDI 100 MONITOR
Received Apr 17, 2012 · Event occurred Mar 23, 2012
Report 1828100-2012-00314 · MDR key 2547942
Device
Product problems
- Malposition of Device
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
EVALUATION IN PROGRESS, BUT NOT YET CONCLUDED. THE USER SWITCHED THE BATTERY OUT AND THEN PROCEEDED TO SETUP FOR THE SURGERY.
Description of Event or Problem
IT WAS REPORTED THAT DURING PREPARATION OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THAT THE BATTERY WAS FOUND ON THE FLOOR AND NOT IN THE MONITOR. AS A RESULT, AN ALTERNATE BATTERY WAS EMPLOYED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO DELAYS, NO BLOOD LOSS OR NO ADVERSE CONSEQUENCES TO THE PATIENT. INVESTIGATION IN PROCESS, BUT NOT YET COMPLETED.